1. Field of the Invention
This invention relates to a compact, hand-held instrument which enables a physician to perform a relatively quick and simple procedure to accurately and controllably implant, dispense and inflate an inflatable membrane (e.g. a genitourinary prosthesis) at a predetermined target area within the urethral tissues of a patient to enable a patient to overcome urinary incontinence by means of increasing both localized tissue volume and passive occlusive pressure proximal to the periurethral tissues of the proximal corpus spongiousum.
2. Prior Art
As will be known to those skilled in the art, in cases where the natural sphincter muscles of a patient have been surgically excised, damaged by disease or compromised by physical trauma, an artificial prosthetic sphincter has often been implanted so that occlusive pressure may be applied to the urethra to restore continence. Artificial sphincters are well-known and specific examples thereof will not be listed. However, the implantation of an artificial sphincter commonly requires a surgical procedure which necessitates the hospitalization of the patient. Such a procedure is relatively complex and expensive, and usually requires six to eight weeks or more of recovery time. Accordingly, both the patient and his physician face approximately two months of delay before being able to activate the prothesis to ascertain whether the surgery has been successful and the patient is continent. More particularly, because of the swollen and aggravated condition of edema of the urethral tissues during and for a period subsequent to surgery, the physician cannot precisely match the occlusive pressure available from the prosthetic sphincter to the patient's urethra. Therefore, at the time of implant, the physician must estimate the required minimal occlusive pressure needed to achieve urethral coaptation in that particular patient. As a consequence of such estimate, sphincteric mechanisms are often improperly fitted or selected with inaccurate pressure ranges, so that the occlusive pressures generated by such mechanisms are either insufficient to successfully achieve continence or excessive to the point of causing ischemia and subsequent necrosis and erosion of urethral tissue. Excessive occlusive forces may undesirably minimize arteriovascular blood flow to the urethra and thereby cause ischemia and subsequent erosion of the delicate tissues. What is more, if the implant surgery should prove to be unsuccessful (i.e. the maximum occlusive pressure to be generated by the sphincter is insufficient to hold the patient incontinent or the sphincter malfunctions mechanically), then additional surgery becomes necessary to provide sphincteric adjustment, repair or explant.
Consequently, there is no apparatus or relatively simple, non-surgical procedure known to be available by which a physician may reliably and safely implant a genitourinary prosthesis to enable a patient to overcome urinary incontinence. While it has been suggested that urinary incontinence may be successfully treated with a periurethral injection of TEFLON paste, this treatment has been known to lead to potential problems as a result of the migration of paste particles from the injection site.